Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients
Recruitment status was: Recruiting
This is a Phase III open-labed, multicenter, prospective, randomised study, and comparative 3-arms of 140 patients (i.e. 420 total patients).
Study period (date of first inclusion/last inclusion): 3 years Treatment period : 3 months
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients : Phase III Randomised Study|
- Evaluation of the prevalence of symptomatic or asymptomatic deep venous thrombosis in cancer patients with implantable device for central venous access with or without prophylaxis :
- Low molecular weight Heparin (LMWH) 2500 U anti-XA/day or Warfarine 1 mg/day during the first line of chemotherapy
- - Detection of asymptomatic thrombosis related to implantable device estimated by a systematic echo-doppler. -
- - Frequency of other symptomatic venous thromboembolic events between 3 groups.
- Comparison of thrombosis prophylaxis by LMWH with warfarin at low dose
- -Costs in the 3 strategies
- - Tumoral response to chemotherapy in the 3 groups.
- - Overall survival in each group.
|Study Start Date:||August 1999|
|Estimated Study Completion Date:||December 2009|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00199602
|Limoges, France, 87000|
|Principal Investigator:||Nicole TUBIANA-MATHIEU, MD||University Hospital, Limoges|